Prospective Comparison of 18F-choline PET/CT and 18F-FDG PET/CT in the Initial Work-up of Multiple Myeloma (MYELOCHOL)

May 11, 2026 updated by: University Hospital, Bordeaux
Multiple myeloma (MM) survival has been improved during the last decade owing to new treatments. Hence, it has become a matter of importance to precisely define the depth of MM response to therapy. 18F-FDG PET/CT (FDG-PET) has proved to be superior to X-rays for the initial staging of MM. It is now recommended by the International Myeloma Working Group (IMWG) during the initial work-up and for response evaluation, as it is superior to MRI in that setting. However, sensitivity of FDG-PET remains inferior to that of MRI for the initial staging of MM. Indeed, FDG-PET remains limited for the evaluation of skull lesions (due to brain physiological background) or spine infiltrative disease. Therefore, there is a need for a new diagnostic tool which could have equivalent sensitivity to that of MRI at diagnosis, and could bring better baseline information than FDG PET for therapy evaluation. Ultimately, this tool would be a one-stop-shop exam for diagnosis and patient follow-up during treatment. 18F-Choline, a tracer of phospholipids of cell membrane, has shown potential as compared to 18F-FDG in a recent retrospective study, with about 70% more lesions detected in MM patients with suspected relapsing disease. Following that perspective, our main objective is to compare prospectively, in a cohort of newly diagnosed MM, the detection rate of MM lesions by 18F-Choline PET/CT (FCH-PET) vs. FDG-PET. Our secondary objectives will be to compare the performance of both PET modalities as regard to MRI as well as the detection rate of extra-medullary lesions. Patients with MM will proceed to FCH-PET, FDG-PET and then Whole-Body MRI within 3 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pessac, France, 33604
        • Bordeaux University Hospital - Haut-Lévêque

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Symptomatic Multiple Myeloma on first-line treatment as defined by 2014 International Myeloma Working Group criteria
  • Measurable disease either by serum or urinary monoclonal protein level or by serum free light chains assay
  • Age > 18 years old at time of signed consent
  • Beneficiary of social security insurance
  • Signed informed consent

Exclusion Criteria:

  • Previous Multiple Myeloma treatment
  • Previous cancer with less than 5 year of complete remission (including plasmacytoma)
  • Chemotherapy in the 6 months preceding the inclusion
  • Uncontrolled diabetes mellitus
  • Medullary growth factor injection less than 48 hours before imaging procedures
  • Ongoing corticosteroid therapy, or given less than 72 hours before PET-CT imaging
  • Pregnant or nursing (lactating) women
  • Childbearing potential woman without adequate barrier contraception method (HAS criteria)
  • Freedom deprivated patient by judiciary or administrative decision
  • Patient under legal protection or unable to express its own consent
  • PET contraindication (known allergy to 18F-FCH or 18F-FDG or excipient)
  • MRI contraindication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Symptomatic Multiple Myeloma on first-line treatment
Drug: Positron Emission Tomography using 18F-FCH
Positron Emission Tomography imaging coupled with scanner (PET-CT). with the injection of a radiopharmaceutical drug, the 18F-FCH(or fluorocholine) for the detection of bone lesions
Drug: Positron Emission Tomography using 18F-FDG
Positron Emission Tomography imaging coupled with scanner (PET-CT). with the injection of a radiopharmaceutical drug, the 18F-FDG (or fluorodeoxyglucose) for the detection of bone lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of whole-body bone lesions
Time Frame: Day 0
The numbers of bone lesions detected by 18F-FCH PET-CT and that are suspected to be related to multiple myeloma, will be counted. Every bone lesion will be validated by the reference test which is composed of MRI standard sequences plus whole-body diffusion MRI. A bone lesion that is not present on MRI but is present on any of the PET modalities must be validated by an expert multidisciplinary consensus.
Day 0
Number of whole-body bone lesions
Time Frame: Day 7
The numbers of bone lesions detected by 18F-FDG PET-CT, and that are suspected to be related to multiple myeloma, will be counted. Every bone lesion will be validated by the reference test which is composed of MRI standard sequences plus whole-body diffusion MRI. A bone lesion that is not present on MRI but is present on any of the PET modalities must be validated by an expert multidisciplinary consensus.
Day 7
Number of bone lesions within defined skeletal areas
Time Frame: Day 0
Six skeletal areas are defined : skull - spine - pelvis - sternum and ribs - superior limbs - inferior limbs. The number of bone lesions that are suspected to be related to myeloma in each of these skeletal area is assessed on 18F-FCH PET-CT Every bone lesion will be validated by the reference test which is composed of MRI standard sequences plus whole-body diffusion MRI. A bone lesion that is not present on MRI but is present on any of the PET modalities must be validated by an expert multidisciplinary consensus
Day 0
Number of bone lesions within defined skeletal areas
Time Frame: Day 7
Six skeletal areas are defined : skull - spine - pelvis - sternum and ribs - superior limbs - inferior limbs. The number of bone lesions that are suspected to be related to myeloma in each of these skeletal area is assessed on 18F-FDG PET-CT. Every bone lesion will be validated by the reference test which is composed of MRI standard sequences plus whole-body diffusion MRI. A bone lesion that is not present on MRI but is present on any of the PET modalities must be validated by an expert multidisciplinary consensus
Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance for the detection of focal bone lesions
Time Frame: Day 0
Sensitivity, specificity, positive predictive value, negative predictive value and accuracy of 18F-FCH PET-CT will be calculated based on two different reference test. First reference test will be standard MRI sequences (T1SE, T2-STIR). Second reference test will be composed of standard MRI sequences plus whole-body diffusion MRI acquisitions.
Day 0
Diagnostic performance for the detection of focal bone lesions
Time Frame: Day 7
Sensitivity, specificity, positive predictive value, negative predictive value and accuracy of 18F-FDG PET-CT will be calculated based on two different reference test. First reference test will be standard MRI sequences (T1SE, T2-STIR). Second reference test will be composed of standard MRI sequences plus whole-body diffusion MRI acquisitions.
Day 7
Diagnostic performances for the detection of diffuse infiltrative disease of the spine
Time Frame: Day 7
Sensitivity, specificity, positive predictive value, negative predictive value and accuracy of 18F-FDG PET-CT will be calculated based on standard MRI sagittal acquisitions of the spine.
Day 7
Diagnostic performances for the detection of diffuse infiltrative disease of the spine
Time Frame: Day 0
Sensitivity, specificity, positive predictive value, negative predictive value and accuracy of 18F-FCH PET-CT will be calculated based on standard MRI sagittal acquisitions of the spine.
Day 0
Number of extra-medullary lesions
Time Frame: Day 7
Each extra-medullary lesion detected on 18F-FDG PET-CT will be validated by an expert multidisciplinary consensus
Day 7
Number of extra-medullary lesions
Time Frame: Day 0
Each extra-medullary lesion detected on 18F-FCH PET-CT will be validated by an expert multidisciplinary consensus
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2019

Primary Completion (Actual)

January 27, 2023

Study Completion (Actual)

January 31, 2023

Study Registration Dates

First Submitted

March 25, 2019

First Submitted That Met QC Criteria

March 25, 2019

First Posted (Actual)

March 27, 2019

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2017/32
  • 2018-003926-10 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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